Biotech QA Specialist: Quality, Compliance & Validation

SGS Consulting; Charlotte (NC); On-site; USD 95,000 - 140,000; Full time

Job summary

SGS Consulting in Charlotte, NC is seeking an experienced QA professional to lead qualification and validation activities within a biotech manufacturing environment. You will provide hands-on QA support to internal staff and suppliers, ensuring compliance with GMP, FDA, EMA, and ICH guidelines.

Responsibilities include QA review and approval of commissioning/qualification/validation documents, deviations, and CAPA; coaching cross-functional teams on risk-based qualification and the application

Qualifications

• BS or MS in Biological/Physical/Chemical sciences, engineering, or equivalent with 3–5+ years QA in biologics manufacturing.
• Experience with qualification/validation of process equipment, analytical instruments, clean utilities, automation, sterile filling, and clean facilities.
• Strong understanding of FDA/EMA/ICH guidelines and GMP best practices.

Responsibilities

• Provide hands-on QA support and oversight to ensure compliance with local and global quality standards, regulatory requirements, and industry guidance.
• Provide QA review and approval for commissioning/qualification/validation documents.
• Review and approve qualification/validation deviations and support investigations and CAPA.
• Coaching site teams on GMP principles and fostering a Quality Culture.
• Author/review controlled documents (SOPs, specs, protocols, reports).
• Assist in regulatory inspections (FDA/EMA/DHHS) as needed.

Skills

QA validation

Regulatory knowledge

GMP compliance

Risk-based qualification

Analytical skills

Root cause analysis

Documentation proficiency

Team collaboration

Communication skills

Problem solving

Education

BS/MS in sciences/engineering

Job description

SGS Consulting in Charlotte, NC is seeking an experienced QA professional to lead qualification and validation activities within a biotech manufacturing environment. You will provide hands-on QA support to internal staff and suppliers, ensuring compliance with GMP, FDA, EMA, and ICH guidelines.

Responsibilities include QA review and approval of commissioning/qualification/validation documents, deviations, and CAPA; coaching cross-functional teams on risk-based qualification and the application